HospitalismNCT03727685
Disseminating a Digital ACP Platform (Our Care Wishes) to Hospitalized Patients
A study testing Our Care Wishes in people with Hospitalism, run by University of Pennsylvania at 1 site in United States.
Trial summary
Penn Medicine has created a novel, online, evidence-based advance care planning (ACP) platform through its Center for Health Care Innovation. The platform is called "Our Care Wishes" and utilizes a 'shopping-cart' approach to ACP, allowing users to name surrogate decision makers, make choices about quality of life and… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hospitalism
- What is being tested?
- Our Care Wishes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,020 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2019to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult admitted at the University of Pennsylvania via two locations: the Emergency Department, Silverstein 1 admission office;
- Patients that are seen in the Pre-Admission Testing (PAT) clinic
- Patients must speak English fluently
Who cannot join
- Maternity patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Multi-channel Dissemination of Information for Digital Advance Care Planning Platform (Our Care Wishes) to Hospital Admits
Penn Medicine has created a novel, online, evidence-based advance care planning (ACP) platform through its Center for Health Care Innovation. The platform is called "Our Care Wishes" and utilizes a 'shopping-cart' approach to ACP, allowing users to name surrogate decision makers, make choices about quality of life and medical treatments, outline medical wishes and organ donation, and share preferences for their end of life experience. Our Care Wishes then creates an easy to read, updatable ACP document that can be electronically shared with loved ones and uploaded to a patient's electronic medical record in PennChart.
It is believed that this platform may help to overcome engagement and infrastructure barriers previously identified in the literature regarding the completion of ACP documents. The intervention will consist of multi-channel information dissemination regarding Our Care Wishes to Hospital of the University of Pennsylvania patients admitted through two locations (the Emergency Department, Silverstein 1 Admission Office) and outpatients who are seen in Pre-Admission Testing (PAT). All patients visiting these two locations during the intervention phase will receive a paper handout with information regarding Our Care Wishes included in their customary admission folder packet. The registration representative (RR) at these three locations will provide a brief explanation of the site as they check the patients in, as well send the patients a direct link to the site for non-ED admits via email and text message.
Read the detailed description
Registration representatives (RR) from Silverstein 1 Admission Office, the Emergency Department, and the Pre Admission Testing office will be administering the intervention at the three sites. The current workflow is for the RR to provide all new admits with an admission packet created by Guest Services and also ask ALL patients whether they have completed an Advance Directive as mandated by the Patient Self-Determination Act of 1991 with little attention paid to encouraging AD completion. During the control/baseline phase of this trial, this workflow will remain the same.
During the intervention phase, a flyer describing the Our Care Wishes platform will be added to the back pocket of admission packets for patients being admitted via the Silverstein 1 Admission Office and the Emergency Department and for patients being seen in the Pre Admission Testing office. The interventions will vary slightly between Silverstein 1/PAT and the Emergency Department given concern for limited bandwidth by RR in the ED setting.
For patients admitted through Silverstein 1 and who visit PAT, they will present to the RR per usual and the RR will follow the current workflow. At the point where the RR asks the patient if they have an AD and if it is present, the RR will remind the patient of the importance of having a document that records their care wishes. The RR will then inform the patient that Penn has created a free, online resource called Our Care Wishes to help patients with Advance Care Planning. The platform allows patients to upload their wishes right into PennChart using their MyPennMedicine login. The RR will then show the flyer in the back pocket of the admission folder to the patient. For patients being admitted via Silverstein 1 Admission Office and those being seen in the Pre Admission Testing office, the RR will then proceed to ask patients if they would like to be sent a link to Our Care Wishes by email or text. For those patients who respond affirmatively, the RR will ask for the preferred email or phone number and will then complete the necessary fields to refer on www.ourcarewishes.org/refer.
For patients admitted through the Emergency Department, a weekly report will be created that generates a list of admissions during the prior week along with their active PennChart email address and date of death if applicable (maternal and child health will be excluded). The research coordinator will email non-deceased patients 7-14 days after their admission date. The email will be sent to patients with an email address in PennChart. The email will not include any personally identifiable information regarding the patient or mention of their recent admission/visit. The email will include high-level information regarding Our Care Wishes, effectively summarizing the information that the patient received in their admission folder and stating the value of ACP, along with a direct link to access Our Care Wishes.
For this process, it is estimated that the RR will spend 60-90 seconds noting the presence of the handout in the admissions folder and sending the patient a direct link (for those that opt-in). Frequency of the intervention will be every patient admitted via Silverstein 1 Admissions office and seen in Pre-Admission Testing during the intervention timeframe.
Each week, a report will be constructed via EPIC reporting to identify the patients that are admitted via these offices during this timeframe. The report will be made available to only key personnel on this research study. The report will also include this information which is routinely collected during the course of a hospitalization:
- Demographics (date of birth, sex, etc.)
- Date of death (if recorded in the EHR)
- Place of death (if recorded in the EHR)
- Dates of hospitalization(s)
- Contact information (email address and mobile phone number)MRN
- HAR
- Name
- Unit admitted to
- Presence of AD in EHR
- Admission source (need ED and Silver 1)
- Outside hospital transfer? (exclude if yes)
- Mother/baby? (exclude if yes)
- PAT appointment date
- Conditions
- Hospitalism
- Being tested
- Our Care Wishes
- Keywords
- Advance care planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Our Care WishesBehavioural
A flyer describing the Our Care Wishes platform will be added to the back pocket of admission packets for patients being admitted via the Silverstein 1 Admission Office and the Emergency Department and for patients being seen in the Pre Admission Testing office. Registration reps in these locations will inform all patients seen that Penn has created a free, online resource called Our Care Wishes to help patients with Advance Care Planning and ask if they would like to be sent a link to Our Care Wishes by email or text. For those patients who respond affirmatively, the rep will then complete the necessary fields to refer on www.ourcarewishes.org/refer.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Patients admitted to the hospital will not receive information about Our Care Wishes. |
| Intervention: Our Care Wishes | Active comparator | Patients admitted to the hospital during the intervention phase will receive information from registration representatives regarding Our Care Wishes. Receives: Behavioral: Our Care Wishes |
What is being measured
The primary outcome is the main question the study is designed to answer.
New Presence of ACP
Presence of an uploaded advance care planning document that shares any care wishes or preferences (beyond simply naming a surrogate)
Measured: within two months of the index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start25 Feb 2019
- Primary completion2 Dec 2019
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HospitalismStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The design is a stepped-wedge cluster design in which specific areas of the hospital will adopt the intervention, in sequence. All areas of the hospital will begin in the control phase. 12 weeks into the study period, the first "wedge" or area of the hospital will adopt the Our Care Wishes intervention, 4 weeks after, the next wedge will switch the control phase, the final wedge will adopt the intervention after that.
- Masking
- None (open label)
- Enrolment
- 16,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Halpern, University of Pennsylvania
- Investigators
- Scott D Halpern, Ph.D, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727685
- Sponsor's protocol ID
- 831901
- Status last verified
- Jun 2023
- First submitted
- 30 Oct 2018
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-channel Dissemination of Information for Digital Advance Care Planning Platform (Our Care Wishes) to Hospital Admits
- ClinicalTrials.gov ID
- NCT03727685
- Acronym / sponsor ID
- 831901
- Conditions
- Hospitalism
- Keywords
- Advance care planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16,020 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Penn Medicine has created a novel, online, evidence-based advance care planning (ACP) platform through its Center for Health Care Innovation. The platform is called "Our Care Wishes" and utilizes a 'shopping-cart' approach to ACP, allowing users to name surrogate decision makers, make choices about quality of life and medical treatments, outline medical wishes and organ donation, and share preferences for their end of life experience. Our Care Wishes then creates an easy to read, updatable ACP document that can be electronically shared with loved ones and uploaded to a patient's electronic medical record in PennChart.
It is believed that this platform may help to overcome engagement and infrastructure barriers previously identified in the literature regarding the completion of ACP documents. The intervention will consist of multi-channel information dissemination regarding Our Care Wishes to Hospital of the University of Pennsylvania patients admitted through two locations (the Emergency Department, Silverstein 1 Admission Office) and outpatients who are seen in Pre-Admission Testing (PAT). All patients visiting these two locations during the intervention phase will receive a paper handout with information regarding Our Care Wishes included in their customary admission folder packet. The registration representative (RR) at these three locations will provide a brief explanation of the site as they check the patients in, as well send the patients a direct link to the site for non-ED admits via email and text message.
Detailed description
Registration representatives (RR) from Silverstein 1 Admission Office, the Emergency Department, and the Pre Admission Testing office will be administering the intervention at the three sites. The current workflow is for the RR to provide all new admits with an admission packet created by Guest Services and also ask ALL patients whether they have completed an Advance Directive as mandated by the Patient Self-Determination Act of 1991 with little attention paid to encouraging AD completion. During the control/baseline phase of this trial, this workflow will remain the same.
During the intervention phase, a flyer describing the Our Care Wishes platform will be added to the back pocket of admission packets for patients being admitted via the Silverstein 1 Admission Office and the Emergency Department and for patients being seen in the Pre Admission Testing office. The interventions will vary slightly between Silverstein 1/PAT and the Emergency Department given concern for limited bandwidth by RR in the ED setting.
For patients admitted through Silverstein 1 and who visit PAT, they will present to the RR per usual and the RR will follow the current workflow. At the point where the RR asks the patient if they have an AD and if it is present, the RR will remind the patient of the importance of having a document that records their care wishes. The RR will then inform the patient that Penn has created a free, online resource called Our Care Wishes to help patients with Advance Care Planning. The platform allows patients to upload their wishes right into PennChart using their MyPennMedicine login. The RR will then show the flyer in the back pocket of the admission folder to the patient. For patients being admitted via Silverstein 1 Admission Office and those being seen in the Pre Admission Testing office, the RR will then proceed to ask patients if they would like to be sent a link to Our Care Wishes by email or text. For those patients who respond affirmatively, the RR will ask for the preferred email or phone number and will then complete the necessary fields to refer on www.ourcarewishes.org/refer.
For patients admitted through the Emergency Department, a weekly report will be created that generates a list of admissions during the prior week along with their active PennChart email address and date of death if applicable (maternal and child health will be excluded). The research coordinator will email non-deceased patients 7-14 days after their admission date. The email will be sent to patients with an email address in PennChart. The email will not include any personally identifiable information regarding the patient or mention of their recent admission/visit. The email will include high-level information regarding Our Care Wishes, effectively summarizing the information that the patient received in their admission folder and stating the value of ACP, along with a direct link to access Our Care Wishes.
For this process, it is estimated that the RR will spend 60-90 seconds noting the presence of the handout in the admissions folder and sending the patient a direct link (for those that opt-in). Frequency of the intervention will be every patient admitted via Silverstein 1 Admissions office and seen in Pre-Admission Testing during the intervention timeframe.
Each week, a report will be constructed via EPIC reporting to identify the patients that are admitted via these offices during this timeframe. The report will be made available to only key personnel on this research study. The report will also include this information which is routinely collected during the course of a hospitalization:
- Demographics (date of birth, sex, etc.)
- Date of death (if recorded in the EHR)
- Place of death (if recorded in the EHR)
- Dates of hospitalization(s)
- Contact information (email address and mobile phone number)MRN
- HAR
- Name
- Unit admitted to
- Presence of AD in EHR
- Admission source (need ED and Silver 1)
- Outside hospital transfer? (exclude if yes)
- Mother/baby? (exclude if yes)
- PAT appointment date
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The design is a stepped-wedge cluster design in which specific areas of the hospital will adopt the intervention, in sequence. All areas of the hospital will begin in the control phase. 12 weeks into the study period, the first "wedge" or area of the hospital will adopt the Our Care Wishes intervention, 4 weeks after, the next wedge will switch the control phase, the final wedge will adopt the intervention after that.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Patients admitted to the hospital will not receive information about Our Care Wishes. |
| Intervention: Our Care Wishes | Active comparator | Behavioral: Our Care WishesPatients admitted to the hospital during the intervention phase will receive information from registration representatives regarding Our Care Wishes. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult admitted at the University of Pennsylvania via two locations: the Emergency Department, Silverstein 1 admission office;
- Patients that are seen in the Pre-Admission Testing (PAT) clinic
- Patients must speak English fluently
Key exclusion criteria (1 listed)
- Maternity patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Our Care WishesA flyer describing the Our Care Wishes platform will be added to the back pocket of admission packets for patients being admitted via the Silverstein 1 Admission Office and the Emergency Department and for patients being seen in the Pre Admission Testing office. Registration reps in these locations will inform all patients seen that Penn has created a free, online resource called Our Care Wishes to help patients with Advance Care Planning and ask if they would like to be sent a link to Our Care Wishes by email or text. For those patients who respond affirmatively, the rep will then complete the necessary fields to refer on www.ourcarewishes.org/refer. | Behavioural | Intervention: Our Care Wishes |
Primary outcome
New Presence of ACP
Time frame: within two months of the index visit
Presence of an uploaded advance care planning document that shares any care wishes or preferences (beyond simply naming a surrogate)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Main interventionLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott D Halpern, Ph.D, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Our Care Wishes in people with Hospitalism, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New Presence of ACP (time frame: within two months of the index visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.